FDA Medical Device Recalls (openFDA)
GE Medical Systems, LLC: GE Healthcare, GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
- Recall number
- Z-0136-2010
- Recalling firm
- GE Medical Systems, LLC
- Product
- GE Healthcare, GE Innova 2100 IQ Versatile Cardiac and Vascular Imaging System, (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector)
- Status
- Terminated
- Initiated
- 2009-04-16
- Posted
- 2009-11-09
- Terminated
- 2015-12-03
- Reason
- Potential pump failure associated with the Coolix 4000 chiller of the Innova single plane and biplane systems that may stop the chiller from working. If a chiller failure occurs, the user will be informed with a message on the n-room monitor stating that three minutes are left before the X-ray is inhibited. This could lead to a delay in treatment and possible additional X-ray exposure and contra
- Root cause
- Device Design
- Action
- Consignees were sent on May 1, 2009 a GE Healthcare " Urgent Medical Device Correction" letter dated April 16, 2009. The letter was addressed to Hospital Administrator/ Risk Manger, Mangers of Radiology/ Cardiology, and Radiologists/ Cardiologists. The letter described the problem, Safety Issue, Affected Product Details, Safety Instructions, Product Correction and Contact Information.
- Quantity
- 60
- Distribution
- Worldwide distribution: USA, ARGENTINA, BELGIUM, BRAZIL, BULGARIA, CHINA, CROATIA, EGYPT, FRANCE, GERMANY, HONG KONG, HUNGARY, INDIA, ITALY, JAPAN, REPUBLIC OF KOREA, LATVIA, LIBYA, MEXICO, NORWAY, POLAND, RUSSIA, SINGAPORE, SPAIN, SWEDEN, TAIWAN, TURKEY, UNITED KINGDOM, ROMANIA, ISRAEL, UKRAINE, YEMEN, BELARUS, and AUSTRALIA.
- Lot, serial or model codes
- SYSTEM ID: 850060731 853060205 82416020006 82416090003 82416120015 82416120016 82416210014 83016022101218 83016842101519 0002780363 00052VAS04 00052VAS05 00060VAS03 010120RX44 082416030012 082416130029 083016002001498 083016802101749 083016822101709 083016862101268 0910064010 110019RX13 1299563 17005VAS01 304526INNOVA 318449INNOVA3 407321INCL2 410368INNOVA1 503561CL1 503561CL4 526354XR13 573815BCR3 603882CATH1 609757IN2100 706774HT4 717217INN21 717544GECATH2 732776CATH4 732923INN 816347SLE2100 816861KCVAI2 816861KCVAI2 818INNOVAHMS1 828315FEP 910343NHIN3 A5152993 A5330714 B5483438 BG4033VA01 C5123626 GOLD010016 HR4106VA01 HR4107VA01 HU1173VA03 LV4000VA04 M4183841 M4484974 RO1180VA01 RU3301VA01 YV0562
- 510(k) numbers
- ["K050489","K052157","K052412","K061163"]
- PMA numbers
- not on file
- Product code
- IZI
- Firm FEI
- 2126677
- Firm city
- Waukesha
- Firm state
- WI
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28